. "6 Improving Human Research Participant Protection Program Performance and Clarifying Roles." Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press, 2002.
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Responsible Research: A Systems Approach to Protecting Research Participants
STATUS OF ACCREDITATION
In its first report, Preserving Public Trust, this committee recommended the careful implementation of pilot projects for nongovernmental accreditation programs for HRPPPs and the research organizations responsible for them (IOM, 2001a). This recommendation was based on the potential for a constructive, performance-based accreditation system to facilitate within protection programs an emphasis on outcome measures as well as to provide a proactive, responsive mechanism that was able to incorporate feedback from accreditation stakeholders in order to meet evolving program needs. Further, participation in accreditation programs is a form of QA, as efforts to prepare to meet accreditation standards should ordinarily have beneficial effects, and at a minimum, will help ensure that programs will conduct self-assessments, presumably noting and addressing deficient areas.
Accreditation has considerable potential to systematize and accelerate QI processes. Site visits by accreditation programs determine if activities meet the standards set by the accreditation process and whether the organization has documented that it meets them. In addition, however, they require the organization to demonstrate that it has undertaken individualized local efforts to improve its activities. For example, the National Committee for Quality Assurance (NCQA) accreditation program, recommended in Preserving Public Trust as a suitable pilot program for the Department of Veterans Affairs (VA) medical centers, identified numerous areas in which it will review program QI activities. The expectation is that programs routinely collect QI data, systematically perform QI studies and analyses, and act to implement them. Examples explicitly identifying QI requirements in the NCQA standards include the following:
databases and information systems that provide QI data;
compliance in drug/device studies, correction of deficiencies;
adequacy and effectiveness of Research ERB processes; and
appropriate investigator conduct of informed consent process (NCQA, 2001).
Accreditation site visits provide a mechanism for identifying performance deficiencies, as well as for finding and commending strengths and excellent program performance. Accreditation organizations, such as the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) and NCQA, as well as federal agencies participating in and promoting accreditation, can expedite the wider adoption of best practices by identifying them and, with the permission of the particular program, extending their reach through broader dissemination.6
Included within the AAHRPP website is a section devoted to the dissemination of Best Practices identified in the course of accreditation evaluations (www.aahrpp.org/best_practices.htm).